A more comprehensive look at Intercept Pharmaceuticals Inc.’s Phase III REGENERATE study of obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH) seemed to bolster the drug’s efficacy case, but investors drove the company’s stock price down April 11, perhaps due to increasing concerns about discontinuation rates seen in the study due to pruritus.
Intercept's OCA Data Bolster NASH Efficacy, But Pruritus Worries Worsen
Analysts call Intercept sell-off overblown in wake of EASL presentation of fuller Phase III data for OCA in NASH. But while depth is added to efficacy argument, pruritus concerns possibly worsen.
More from Clinical Trials
• By
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
• By
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.
• By
The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.
• By
Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.
More from R&D
• By
A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.
• By
The UK giant is forecasting peak sales of $5bn plus
• By
Novo’s semaglutide has shown its benefits as an injectable in patients with peripheral arterial disease and as an oral agent in cardiovascular outcomes, but stronger results are expected soon from Lilly’s tirzepatide.